PMA P030005S226
- Device
- VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S226
- Product code
- NKE
- Decision date
- 2022-12-14
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Add a new cleanroom to the BSC-Clonmel manufacturing facility.
Current openFDA PMA Record#
- Device
- VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S226
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-12-14
- Decision code
- OK30
- Date received
- 2022-12-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new cleanroom to the BSC-Clonmel manufacturing facility.